Dermacyd in Odor Reducing.

Phase 3

Completed

• Conditions: Hygiene
• Interventions: Drug: LACTIC ACID (Dermacid); Drug: Glycerine Vegetal Soap Granado Traditional

• Registration Number: NCT01158365
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

- To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional

Secondary Objective:

- To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-03
• Last Update Posted: 2011-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dermacyd (different fragrances)	LACTIC ACID (Dermacid)	Day 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional
Dermacyd (different fragrances)	Glycerine Vegetal Soap Granado Traditional	Day 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional
Glycerine Vegetal Soap Granado Traditional	LACTIC ACID (Dermacid)	Day 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd)
Glycerine Vegetal Soap Granado Traditional	Glycerine Vegetal Soap Granado Traditional	Day 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd)

Primary Outcome Measures

Name	Time	Method
Reduction of genital odor and increase hydration in genital mucosa	From the treatment start to the end of the study (day 67)	Patient's questionnaire will be completed at V1, V2 and V4. Reduction of vaginal odor, increase in the moisture area, and perception about some items like foam, facility of rinsing, final touch of the mucosa, final fragrance, and cleaning sensation will be rated on a 5-point scale.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the integrity of the mucosa	From the treatment start to the end of the study (day 67)	Onset of erythema, edema, scaling, blisters or other clinical sign will be evaluated.

Trial Locations

Locations (1)

Sanofi-Aventis Investigational Site Number 076-001; 🇧🇷 Osasco, Brazil